Item

Standard

Analysis data

Appearance

White fine crystals or White power

conforms

Specific rotation(20/D)

(C=4 in 6N HCL)

-14.9 to -16.0 Degree

-15.6Degree

State of solution

(Transmittance)

Clear and colorless

Not less than 95.0%

98.5%

Chloride (Cl)

Not more than 0.020%

0.02%

Heavy metals(Pb)

Not more than 10ppm

<10ppm

Arsenic(As2O3)

Not more than 1ppm

<1ppm

Isomer content

Not more than 0.5%

conforms

Loss on drying

Not more than 0.20%

0.17%

Residue on ignition(sulfated)

Not more than 0.10%

<0.1%

Purity

Chiral Purity≥99.0%

conforms

Assay

99 to100.5%

99.3%